TMC125-C214 - Early Access of TMC125 in
combination with other antiretrovirals in treatment-experienced
HIV-1 infected subjects with limited treatment options.

PI: Jonathan Moorman, M.D.,
Ph.D.

This is a phase III, expanded access protocol
designed to provide a novel drug, TMC125, to individuals with
HIV-1 infection who have limited treatment options.
Eligible subjects will be recruited from the ETSU Center of
Excellence for HIV based on defined enrollment criteria and be
given TMC125 along with a backbone regimen of ARVs.
Subjects will be provided the drug for as long as is necessary
until FDA approval is given.

A Multi-national, Multi-center,
Double-Blind, Randomized, Parallel Group Study to Compare the
Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg
Vancomycin Taken q6h For Ten Days in Subjects With
Clostridium difficile-Associated Diarrhea

PI: Jonathan Moorman, M.D.,
Ph.D.

This double-blind Phase 3 trial will compare
the safety and efficacy of an investigational antibiotic versus
vancomycin.

At study entry, Visit 1, subjects will be
randomized at each site to receive the oral investigational
antibiotic or oral vancomycin in a double blind manner. Subjects
will be evaluated clinically during and after the 10-day course
of therapy for cure or failure and, if cured, followed for a
four-week period thereafter for recurrence. Clinical response
(cure/failure, recurrence) will be based on the Investigator's
assessment of clinical parameters, most importantly diarrhea. The
subject will be evaluated for changes in the number and character
of stools and for other signs/symptoms or laboratory values
suggestive of CDAD. Toxin A and B assays will be performed at the
End-of-Therapy Visit or Early Termination Visit for subjects who
fail. Subjects who are cured will be evaluated for diarrhea
during the post-therapy follow-up time frame to Study Days 36-40
(Post-study Visit). Subjects with diarrhea will be evaluated for
the presence of toxin A and B. The co-administration of any oral
or parenteral antibacterials will be captured up to the
Post-study Visit (Days 36-40).

A Phase 2, Open-Label, Non-Comparative
Study of Doripenem In The Treatment of Nosocomial And
Ventilator-Associated Pneumonia In Hospitals Where Pseudomonas
aeruginosa May Be A Prevalent Pathogen

PI: Felix Sarubbi, M.D.

This is an open-label, Phase 2,
non-comparative, multicenter study of doripenem involving
approximately 200 adult male and female subjects with NP or VAP
hospitalized at institutions where P. aeruginosa may be a
prevalent pathogen. NP subjects must meet a certain high-risk
profile and VAP subjects must have a Clinical Pulmonary Infection
Score (CPIS) >6 at baseline to be eligible to participate in
the study. At study entry, all eligible subjects will receive
doripenem 1 gram (g) intravenously (i.v.) over 4 hours every 8
hours with a potential dosage adjustment to 500 mg after
approximately 48 hours depending upon the doripenem minimum
inhibitory concentration (MIC) of the pathogen(s).

Subjects will be assessed at: Baseline/Study
Entry (Study Day 1), daily while on study drug, End-of-Therapy
(EOT) within 24 hours of last dose, Test-of-Cure (TOC) 7-14 days
after EOT, and Late Follow-up (LFU) 28-35 days after EOT.

The protocol adheres to all IND and other
pertinent guidelines relevant to the conduct of clinical trials.
Its main objective is to extend solid microbiologic and other
preclinical findings into the patient care arena and establish if
doripenem, a new and more potent carbapenem, is capable of
eradicating VAP-associated pathogens, especially Pseudomonas
aeruginosa, that are resistant to imipenem. It should be considered
exploratory in nature and, accordingly, will be both open-label and
non-comparative in design.